PTSM: Pharmaceutical Technology Sourcing and Management, Jul 9, 2008 - Pharmaceutical Technology

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PTSM: Pharmaceutical Technology Sourcing and Management, Jul 9, 2008
Global Feature
The Economics of Follow-on Biologics
By Patricia Van Arnum
A recent US government study shows that follow-on biologics are likely to have a favorable economic impact if proposed legislation authorizing a regulatory pathway in the US is approved.
Information Technology and Software
Enterprise-Level Change Control
By Matthew Kopecky
Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control.
Outsourcing
Toward a New Model for Contract Manufacturing
By Jim Miller
Global manufacturing excellence will be a game changer for CMOs that can achieve it.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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